US FDA’s current 510(k) process is not kind to small companies, and they should receive special attention as regulatory reform is envisaged, according to what is described as the largest industrywide study ever conducted. Small and medium-size enterprises are the lifeblood of the medical device industry and harbingers of innovation.
Led by John H. Linehan, PhD, of Northwestern University and funded by InHealth, the survey also finds that improvement of regulatory process predictability in the United States must be a key priority for all stakeholders, and especially US FDA. More than two-thirds of medical device companies reported that predictability of the regulatory process is “critically important” for deciding in which country to launch their products. The report is published in the June issue of the Journal of Medical Devices.
In addition to process predictability the report identifies four other key areas needing improvement:
- Regulatory requirements. More than half of survey respondents cited regulatory requirements as one of the top three factors in investment decisions about proceeding with a new device. Almost a quarter of respondents cited it as the top factor.
- Guidance documents. More than two-thirds of respondents felt device-specific guidance documents were critical to preparing a successful submission; 59% stated that device-specific guidance did not exist for their technology.
- Interaction with US FDA. In almost nine out of 10 cases, FDA reviewers asked for additional information on a submission that went beyond what was required in guidance documents, according to survey participants.
- International experience. Compared with the EU process, the US FDA review process was found to be almost twice as long for devices not requiring clinical data and almost three times as long for devices that do.
The full report can be downloaded (payment required) at the Journal of Medical Devices website.Norbert Sparrow